MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 20GA (3F) 0.95MM X 65CM

Model Number	384156
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter was left for 10 days.The hospital used a pre-filled syringe to perform normal flushing operations.The catheter was found to be leaking, the patient was extubated, and the infusion fluid was replaced.This not only caused economic losses, but also added extra work to normal work.Communicate with patients to avoid disputes.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
The catheter was left for 10 days.The hospital used a pre-filled syringe to perform normal flushing operations.The catheter was found to be leaking, the patient was extubated, and the infusion fluid was replaced.This not only caused economic losses, but also added extra work to normal work.Communicate with patients to avoid disputes.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been investigated and reviewed.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One catheter was returned for review.Functional testing confirmed leakage in the catheter tubing.A slit was observed under magnification at the leakage site.A definite root cause for the damage to the catheter could not be established with confidence.It could not be determined if the damage was the result of an event within extrusion, assembly, unit storage, packaging, or within the user environment.Since a definite root cause could not be established, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.
Event or Problem Description
The catheter was left for 10 days.The hospital used a pre-filled syringe to perform normal flushing operations.The catheter was found to be leaking, the patient was extubated, and the infusion fluid was replaced.This not only caused economic losses, but also added extra work to normal work.Communicate with patients to avoid disputes.

• Brand Name: FIRST PICC S/L 20GA (3F) 0.95MM X 65CM
• Common Device Name: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12933569
• Report Number: 0001625425-2021-01197
• Device Sequence Number: 16652228
• Product Code: FOZ
• UDI-Device Identifier: 00886333209675
• UDI-Public: 00886333209675
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2024
• Device Model Number: 384156
• Device Catalogue Number: 384156
• Device Lot Number: 11349101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 11/17/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/04/2022; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown